Clinical Trials Regulatory Associate

Mass General Brigham; Boston (MA); On-site; USD 28,000 - 40,000; Full time

Job summary

Mass General Brigham seeks a Regulatory Compliance Coordinator to ensure clinical trial regulatory requirements are met under supervision. You will collaborate with clinical teams, IRBs, sponsors, and federal agencies, contributing to training and adherence to institutional and federal guidelines.

The role emphasizes accuracy in documentation, timely submissions, and clear communication with stakeholders. Onsite work location is at our Boston-area facilities, with a focus on patient safety and

Qualifications

• Bachelor's degree in a related field is required.
• 1-2 years of experience preferred in clinical research or regulatory affairs.
• Ability to recognize compliance and data integrity issues.

Responsibilities

• Maintain and organize study-specific regulatory binders.
• Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB.
• Revise informed consent documents to include new risk information or updated protocol requirements.
• Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required.
• Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process.
• Collect, complete, and submit essential regulatory documents to various regulatory entities.
• Participate in monitoring visits and maintain a record of all correspondence related to these visits.

Skills

Attention to detail

Compliance awareness

Clinical research protocols

Communication skills

Interpersonal skills

Education

Bachelor's Degree in Related Field

Job description

Mass General Brigham seeks a Regulatory Compliance Coordinator to ensure clinical trial regulatory requirements are met under supervision. You will collaborate with clinical teams, IRBs, sponsors, and federal agencies, contributing to training and adherence to institutional and federal guidelines.

The role emphasizes accuracy in documentation, timely submissions, and clear communication with stakeholders. Onsite work location is at our Boston-area facilities, with a focus on patient safety and